NCT02274818

Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education.

Individualized Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,500 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators are conducting a cluster randomized trial in a sample of 63 internal medicine (IM) training programs that are randomly assigned to either the current duty hour standards or less restricted flexible duty hour standards. The trial includes a main protocol in which all randomized IM programs participate and two substudies. "Time and Motion" and "Sleep and Alertness", each conducted at a subset of IM programs and focusing on more detailed data collection at the intern level. The main protocol will examine patient safety and costs as well as quality of education. The "Time and Motion" substudy examines additional educational outcomes. The "Sleep and Alertness" substudy examines intern sleep time and alertness.

Detailed description

Title: Sleep duration (hours of sleep) as measured with an actigraph Time frame: Measured daily for 14 days Title: Behavioral alertness as measured with Psychomotor vigilance test Time frame: Measured daily for 14 days Title: Self perceived sleepiness as measured by the Karolinska Sleepiness Score Time frame: Measured daily for 14 days Title: Time (hours per day) spent in direct patient care Description: Time spent in direct patient care over 2-4 wks as measured by a trained observer shadowing the intern Time frame: measured daily over 2-4 wks Title: Trainee satisfaction with education Description: Self-reported satisfaction with education as assessed thru survey questions Time frame: measured at baseline and at end of intervention year Title: Program director satisfaction with trainee education Description: Self-reported satisfaction with trainee education as assessed thru survey questions Time frame: measured at baseline and end of intervention year Patient safety and costs: Title: Total costs of patient care as measured by total Medicare payments Time frame: Measured over year of trial

Conditions

• Safety
• Education, Medical
• Sleep

Interventions

Type	Name	Description
BEHAVIORAL	Flexible Duty Hour Schedule	IM programs randomized to intervention will be allowed to construct flexible duty hour schedules that comply with 3 rules: * No more than 80 hours of work per week (when averaged over 4 weeks) * 1 day off in 7 (when averaged over 4 weeks) * In-house call no more frequently than every 3rd night (when averaged over 4 weeks)

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-12-01
• Completion: 2020-06-30
• First posted: 2014-10-24
• Last updated: 2020-09-04